ACTRN12609000046202招募中3 期
A Prospective, Randomized, Open-label, with Blinded Endpoint evaluation (PROBE), multi-center, controlled , clinical trial on the effectiveness of the cytoreductive therapies (i.e. Phlebotomy and Hydroxyurea (HU)) in reducing cardiovascular (CV) deaths and thrombotic events in patients with Polycythemia Vera (PV)
Consorzio Mario Negri Sud0 个研究点目标入组 1,000 人开始时间: 2009年1月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Age > 18 years
- •Diagnosis of PV according to World Health Organisation (WHO) criteria
- •Ability and willingness to comply with all study requirements
- •Written and signed informed consent
排除标准
- •Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
- •Known hypersensitivity or contraindication to study treatments
- •Significant liver (aspartate amino transferasi (AST) or alanine aminotransferasi (ALT) > 2.5 times upper limit normal (ULN)) or renal disease (creatinine > 2 mg/ml)
- •Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
- •History of active substance or alcohol abuse within the last year
- •Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol - Baseline and follow-up (F-UP) visits schedule and assessments
研究者
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